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Venclose RF Ablation System for the Treatment of IPVs

NCT04386785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-05-27

Study results available
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Summary

A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.

Conditions

  • Chronic Venous Insufficiency

Interventions

DEVICE

Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins

The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.

Sponsors & Collaborators

  • Venclose, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Carr, MD · Vein Center of East Texas at CardioStream

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-23
Primary Completion
2021-04-13
Completion
2021-05-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04386785 on ClinicalTrials.gov